NCT03293225

Brief Summary

A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on treatment with H2-receptor antagonist in patients with chronic urticaria

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

September 11, 2017

Last Update Submit

July 4, 2019

Conditions

Chronic Urticaria

Keywords

cu

Outcome Measures

Primary Outcomes (1)

  • Number of evaluation after 4 weeks treatment by a investigator

    0-no effective, 1-ineffective, 2-effective, 3-no symptoms

    4 weeks

Secondary Outcomes (10)

  • Peripheral blood eosinophil count

    4 weeks

  • Number of evaluation as assessed by questionnaire

    4 weeks

  • Number of urticaria control by K-UCT

    4 weeks

  • Number of urticaria symptom by UAS

    4 weeks

  • Quality of life of chronic urticaria by CU-QoL

    4 weeks

  • +5 more secondary outcomes

Study Arms (4)

add H2RA

Add antihistamines to standard drug therapy

change ns-H1RA

Change to ns-H1RA in standard medication

ns-H1RA(3-4 tabs)

Standard treatment with ns-H1RA 4X dose

ns-H1RA(3-4kinds)

Use of NS 4 kinds for standard treatment

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic urticaria in Ajou University Hospital

You may qualify if:

  • Adolescents and adults over 12 years
  • Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks
  • Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled
  • Those who do not have other chronic skin diseases

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Medical Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Youngmin Ye, Dr

    Ajou University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, Department alleric internal medicine

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 26, 2017

Study Start

August 24, 2017

Primary Completion

May 24, 2019

Study Completion

May 24, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)